Introduction

This is an application for analysis of Adverse Event (AE) data from Oncore. The application requires 4 data sets (a 5th tumor measurement file, with RECIST format as response is optional for additional plots). In the OnCore biostats console download the clinical trial data from the “Data Export” page by selecting the protocol number, clicking “Use Descriptions” in export options, and finally click export. See the Oncore data export screen shot.

Demographics
Follow up
Drug administration data
Adverse event data
RECIST data (optional)

Running the app

Once installed run the function runAEapp() to launch a browser with the application and demo data will be loaded.

RECIST data

RECIST (Response Evaluation Criteria in Solid Tumors) is a set of standardized criteria used to assess how well a tumor responds to treatment in clinical trials, particularly for cancer therapies. These criteria provide a consistent method for measuring tumor size and determining changes in tumor burden over time. Developed by an international collaboration of cancer organizations, RECIST ensures that tumor response can be compared across different studies.

Key Aspects of RECIST:

Tumor Measurement: Tumors are classified as target or non-target lesions. Target lesions are selected for precise measurement, while non-target lesions are qualitatively assessed.
- Target lesions are measured in their longest diameter (except for lymph nodes, which are measured in their short axis).
- Up to five target lesions are typically selected for measurement, with a maximum of two per organ.
Response Categories:
- Complete Response (CR): Disappearance of all target lesions.
- Partial Response (PR): At least a 30% decrease in the sum of the diameters of target lesions, compared to the baseline.
- Progressive Disease (PD): At least a 20% increase in the sum of the diameters of target lesions, or the appearance of new lesions.
- Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD.
Evaluation Frequency: Tumor measurements are taken at regular intervals during treatment to monitor changes. The results are used to assess whether the treatment is effective, should be continued, or requires adjustment.

Importance of RECIST:

Standardization: Provides a consistent and objective way to assess tumor response across different clinical trials.
Treatment Evaluation: Helps determine whether a therapy is working by objectively measuring changes in tumor size.
Regulatory Use: Used by regulatory agencies like the FDA and EMA to evaluate the efficacy of new cancer treatments.

Overall, RECIST is a critical tool in oncology research and clinical practice, guiding decisions about patient care and drug approval.

If using tumor measurement/RECIST data the each subject must have baseline measures and follow up measure for the target lesions. The response should be one of the following:

[1] “Baseline (BL)”

[2] “Stable Disease (SD)”

[3] “Progressive Disease (PD)”

[4] “Partial Response (PR)”

[5] “Not Evaluable (NE)”

Data tab

This is the home page (data tab), on the left upload the data. There are multiple tabs to view each of the raw uploaded data sets and the toxicity data is constructed from merging the uploaded data.

Home page data upload.

On the data page there are 5 sub-tabs:

AE data
Demographic data
Follow up data
Drug administration data
Toxicity data